Clinical Study on the Safety and Preliminary Efficacy of hUC-MSCs Intravenous Infusion Therapy for ARDS

NCT06505941 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: 2019ZDSYLL077-P06
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The object of this study is to observe the safety of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome, consisting with two phases.

Conditions

Acute Respiratory Distress Syndrome

Keywords

acute respiratry distress syndrome; human umbilical cord derived mesenchymal stem cell; clinical study

Outcome Measures

Primary Outcomes (1)

• The safety of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome.

  The 28-day mortality of patients receiving umbilical cord mesenchymal stem cell therapy

  The 1, 6, 24 hours; 3、7、14、21 days and 4, 12, 24, 36, 48 weeks after injection.

Secondary Outcomes (1)

• The efficacy of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome.

  The 1, 6, 24 hours; 3、7、14、21 days and 4, 12, 24, 36, 48 weeks after injection.

Study Arms (2)

placebo

PLACEBO COMPARATOR

1 intravenous infusion of an equal volume of cell-free placebo.

Drug: Placebo

MSC

EXPERIMENTAL

Name：Human umbilical cord mesenchymal stem cells Specification: 30 ml/bag Dosage: 1×106cells/kg, 5×106cells/kg, 10×106cells/kg Usage: Intravenous infusion The stem cells used in this study are human umbilical cord mesenchymal stem cells (hUC-MSCs), which are derived from umbilical cords donated by healthy mothers who have given birth in maternity hospitals. hUC-MSCs are extracted, processed, cultured and harvested from umbilical cord donors recruited by laboratories complying with the GMP standards. hUC-MSCs cell suspensions that have passed the quality control will be put into bags and transported to the hospitals for use by the subjects of the present clinical study.

Drug: umbilical cord mesenchymal stem cell

Interventions

umbilical cord mesenchymal stem cell DRUG

umbilical cord mesenchymal stem cell

Also known as: cell

MSC

Placebo DRUG

non-cell-containing placebo

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 years, regardless of gender;
• Meeting the ARDS Berlin diagnostic criteria;
• Definite diagnosis within 72 hours;
• P/F \< 150mmHg;
• Understanding and signing informed consent.

You may not qualify if:

• Women of childbearing potential with a positive serum pregnancy test before medication, pregnant women, or lactating women;
• ARDS directly caused by physical or chemical factors;
• Moderate to severe liver damage (Child-Pugh score \>12);
• Chronic heart failure, New York Heart Association functional class IV;
• Severe kidney disease undergoing renal replacement therapy;
• Severe lung disease, Grade III or IV pulmonary hypertension, receiving oxygen therapy or ventilator support for more than one month in the six months prior to screening, end-stage lung disease, or severe physical limitations due to chest wall deformity;
• Immunodeficiency, receiving immunosuppressive therapy within 2 weeks (except for low-dose corticosteroids), or with lymphoma, leukemia, or acquired immune deficiency syndrome; history of organ transplantation, bone marrow transplantation, or autologous hematopoietic stem cell suppression;
• Expected survival time of less than 48 hours due to terminal illness;
• Patients diagnosed with deep vein thrombosis (DVT) or pulmonary embolism (PE) in the past three months;
• Patients receiving ECMO therapy;
• Hepatitis B, hepatitis C, syphilis, or HIV infection.
• eGFR \< 30ml/min/BSA;
• ALT \> 5 × ULN;
• Absolute neutrophil count \< 1500/μL;
• Subjects who have participated in other clinical studies within the past month (excluding those who have not received intervention), or are currently participating in other experimental treatments;

Sponsors & Collaborators

• Southeast University, China: lead
• Zhongda Hospital: collaborator
• Yinguan Biologics, Shenzheng: collaborator

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Carboxylesterase

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Carboxylic Ester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: deputy director

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: July 17, 2024
• Study Start: July 20, 2024
• Primary Completion: November 20, 2025
• Study Completion (Estimated): February 20, 2027
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share